IMPACT Intervention
A Randomised Controlled Trial to Evaluate the Effectiveness of a Multidisciplinary Team Intervention on Glycaemic Control for Disadvantaged Type 2 Diabetes Patients in France.
Introduction :
The prevalence of type 2 diabetes is increasing in France, especially in deprived districts.
The Itineraires Medico-sociaux Programme d'Accompagnement sur un Territoire (IMPACT) intervention is intended for disadvantaged patients with a chronic disease (not only type 2 diabetes).
The IMPACT intervention offers coordinated and patient-centered care by a multidisciplinary team with an empowerment approach. This personalised intervention lasts 6 months.
This study aims to evaluate the effect of 6 months IMPACT intervention on glycaemic control (glycated haemoglobin - HbA1c) of patients with type 2 diabetes in deprived districts.
Method :
This will be a randomised, controlled, parallel group, multicenter, open-label trial. 140 adults with type 2 diabetes will be randomised in two arms : IMPACT intervention group (n : 70) and usual care group (n : 70). The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 6 months. The primary outcome will be analysed using a linear mixed effects model.
調査の概要
詳細な説明
This will be a randomised, controlled, parallel group, multicenter, open-label trial. Patients will be recruited among patients with type 2 diabetes referred to the IMPACT intervention.
144 patients will be randomised in two arms : IMPACT intervention group (n : 72) and usual care group (n : 72).
IMPACT intervention : a referent is assigned to the patient. A referent is a health worker (nurse, nutritionist, psychologist …). Patient builds with his referent a free care program. The patient can choose individual consultation (for example : nutrition, tabacology, psychology …) and/or collective care (for example : patient education, physical activity, relaxation …). A community health worker can help patients with his health administrative procedures.
Patients will have 3 visits. First visit (inclusion visit) : investigator collects baseline characteristics (sociodemographic data, comorbidity, treatment, diabetes complications, weight, height, body mass index, impedancemetry, HbA1c, lipids, creatinine, albuminuria/creatinuria ratio). Then the patient will be randomised.
Second visit (midpoint visit) : investigator collects weight, BMI, impedancemetry, HbA1c and adverse events Third visit (end point visit) : investigator collects weight, BMI, impedancemetry, HbA1c, lipids and adverse events.
Analysis : The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 6 months. The primary outcome will be analysed using a linear mixed effects model. Study groups, districts, time, group-time interaction and district-group interaction will be included as fixed effects. The model will include patients as a random effect. Sub-group analysis will be made with baseline HbA1c, sex, age, Epices score (French precarity score) and diabetes duration. The robustness of the model will be tested by replacing missing data with multiple imputation methods. The same statistical modelling approach will be used for the secondary outcomes.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Donatien Talon, Resident
- 電話番号:+33679230064
- メール:donatien.talon@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with type 2 diabetes
- Inclusion HbA1c > 7.5%
- Live in Hauts de Chambéry, Biollay or Renaudie district
- Be able to give written consent
Exclusion Criteria:
- Severe cognitive or psychological disorder that may affect study understanding
- Pregnant or breastfeeding women
- Had IMPACT intervention in the previous 24 months
- Concurrent participation in another study
- Concurrent participation in another diabetes educational care program
- Life expectancy less than 6 months
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:対照群
普段のお手入れ
|
|
実験的:Intervention group
IMPACT intervention
|
A referent is assigned to the patient.
A referent is a health worker (nurse, nutritionist, psychologist …).
Patient builds with his referent a free care program (without condition or limit).
The patient can choose individual consultation (for example : nutrition, tabacology, psychology …) and/or collective care (for example : patient education, physical activity, relaxation …).
A community health worker can help patient with his health administrative procedures.
This intervention lasts 6 months.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
HbA1c
時間枠:From baseline to 6 months
|
Change in glycated haemoglobin (HbA1c)
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From baseline to 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
HbA1c
時間枠:From baseline to 3 months
|
Change in glycated haemoglobin (HbA1c)
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From baseline to 3 months
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Weight
時間枠:At Months 3 and 6 from baseline
|
Change in weight
|
At Months 3 and 6 from baseline
|
Body mass index
時間枠:At Months 3 and 6 from baseline
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Change in body mass index
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At Months 3 and 6 from baseline
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Body fat mass (Bioelectrical impedance analysis)
時間枠:At Months 3 and 6 from baseline
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Change in body fat mass
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At Months 3 and 6 from baseline
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Body fat percentage (Bioelectrical impedance analysis)
時間枠:At Months 3 and 6 from baseline
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Change in body fat percentage
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At Months 3 and 6 from baseline
|
Muscle mass (Bioelectrical impedance analysis)
時間枠:At Months 3 and 6 from baseline
|
Change in muscle mass.
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At Months 3 and 6 from baseline
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Lipids - HDL cholesterol
時間枠:From baseline to 6 months
|
Change in HDL cholesterol
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From baseline to 6 months
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Lipids - LDL cholesterol
時間枠:From baseline to 6 months
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Change in LDL cholesterol
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From baseline to 6 months
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Lipids - triglycerides
時間枠:From baseline to 6 months
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Change in triglycerides
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From baseline to 6 months
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, Halperin I, Vachon B, Ramsay T, Manns B, Tonelli M, Shojania K. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012 Jun 16;379(9833):2252-61. doi: 10.1016/S0140-6736(12)60480-2. Epub 2012 Jun 9.
- Attridge M, Creamer J, Ramsden M, Cannings-John R, Hawthorne K. Culturally appropriate health education for people in ethnic minority groups with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2014 Sep 4;(9):CD006424. doi: 10.1002/14651858.CD006424.pub3.
- Captieux M, Pearce G, Parke HL, Epiphaniou E, Wild S, Taylor SJC, Pinnock H. Supported self-management for people with type 2 diabetes: a meta-review of quantitative systematic reviews. BMJ Open. 2018 Dec 14;8(12):e024262. doi: 10.1136/bmjopen-2018-024262.
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2020-A02905-34
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2型糖尿病の臨床試験
IMPACT interventionの臨床試験
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